Newsletter | February 9, 2024

02.09.24 -- Cell & Gene Therapy Regulatory And Compliance Solutions


As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris.

BioPhase 8800 Capillary Electrophoresis System

This multi-capillary electrophoresis system enables scientists to run multiple samples in parallel, accelerating the development and execution of sensitive, high-throughput analytical methods.

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Danaher Life Sciences

Maintaining Data Integrity And Compliance Of Your Osmometer

Data integrity is a leading issue cited in FDA warning letters, mainly due to incomplete data. Learn how this can be prevented by ensuring compliance with data integrity.

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Advanced Instruments, Inc.

Navigating The Advanced Therapy Regulatory Landscape With Expertise

Review the submission process and regulatory expertise which helped a biopharma company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.

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Cardinal Health

Access cGMP Biomanufacturing Capacity Faster

Discover a software solution that enables the rapid, pretested, and pre-verified integration of your bioproduction equipment into a central data storage, visualization, and reporting infrastructure.

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Identifying Operational Improvements For Batch Records And QA

Learn how CAI helped a client reduce their batch record backlog, minimize their manufacturing error rate, sustain timely productivity and release levels, and meet FDA commitments.

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Cleanrooms And Equipment For Gene Therapy Drug Manufacturing

Despite quick growth and logistical challenges, Germfree’s mobile solutions enable distributed manufacturing, ease the collection of patient cells, and help make CGT treatments accessible globally.

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